Hypobaria and Traumatic Pneumothorax

NCT01670942 | Completed

• 1 other identifier: IRB#1024157
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to see if people who have had a collapsed lung that has been re-expanded can be safely taken to an elevation that a person might experience while in a commercial airplane without having their lung partially collapse again, or have any symptoms such as feeling short of breath or having oxygen levels in the blood decrease while at the simulated altitude. The investigators hypothesize that subjects who have had a collapsed lung that has been re-expanded will not have any adverse symptoms or signs while subjected to a simulated altitude of 8400 feet (565mm Hg) or 12650 ft (471mm Hg).

Conditions

Pneumothorax

Keywords

pneumothorax; trauma; commercial air travel

Outcome Measures

Primary Outcomes (1)

• Change in pneumothorax size

  Will document pneumothorax size before simulated altitude, and size after being at simulated altitude for two hours

  baseline and 2 hours

Study Arms (1)

Traumatic Pneumothorax1

hypobaric chamber

Other: hypobaric chamber

Interventions

hypobaric chamber OTHER

We will use a large (26 tons) multi-place hyperbaric and hypobaric chamber at IMC in Murray, Utah (elevation 1500m or 4500ft, average ambient barometric pressure 645mm Hg). In the hypobaric study, the barometric pressure will be lowered to 554mm Hg (phase 1) or 471mm Hg (phase 2) over 20 minutes and held there for two hours.

Traumatic Pneumothorax1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unilateral pneumothorax of traumatic etiology that has been treated with oxygen, observation, or tube thoracostomy

You may qualify if:

• Inpatient status on trauma surgery service
• An established diagnosis of pneumothorax with a traumatic etiology (patients with iatrogenic pneumothorax from attempted central venous line placement will be considered to have a traumatic etiology)
• Age ≥ 18 at the time of injury

You may not qualify if:

• Pregnancy
• Unable to give informed consent
• Pneumothorax which does not satisfactorily resolve after treatment with tube thoracostomy and requires operative intervention such as video assisted thoracoscopic surgery (VATS) or thoracotomy
• Pneumothorax requiring tube thoracostomy where the tube has been removed for \< 4 or \> 48 hours
• Head injury with GCS \< 15 at time of evaluation for study
• Other injuries or conditions which would preclude participant's ability to remain in chamber for two hours
• NYHA class III or IV heart failure, active coronary artery disease, arrhythmias, pacemakers, implantable cardiac defibrillator, pulmonary hypertension, claustrophobia
• Severe obstructive or restrictive lung disease
• Chronic hypoxemia requiring supplemental oxygen
• Hypoxemia for any reason (pulmonary contusion, atelectasis, pneumonia, etc.) requiring \> 3 liters supplemental oxygen at the time of entry into the study
• Inability to tolerate the confines of the chamber

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

MeSH Terms

Conditions

Pneumothorax; Wounds and Injuries

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Sarah Majercik, MD, MBA

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

• Lindell Weaver, MD

  Intermountain Health Care, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MBA, FACS

Study Record Dates

• First Submitted: August 18, 2012
• First Posted: August 23, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 28, 2014

Record last verified: 2014-04

Locations

US (1)